SMIT PATEL
Princeton,USA
Summary
Results-driven professional with expertise in biotech and pharmaceuticals. Proven track record in developing inspection activities, driving compliance, and ensuring quality control, ready to contribute to impactful commercialization strategies.
Overview
2
2
years of professional experience
Work History
Quality Assurance Person
Kesar Pharma PVT. LTD.
Gujarat, India
05.2024 - Current
- Mainly responsible in the development and implementation of inspection activities of the drug manufacturing process.
- Reviewed and assessed batch records, specifications, and certificates of analysis for compliance with regulatory requirements.
- Responsible for different tasks such as documentation management, SOPs handling, risk assessment, GMP audits & quality control oversight.
- Worked on identifying and resolving problems while helping the team in delivering the satisfactory outcomes.
Project: Commercialization Plan
Ranaqua Biosciences, LLC
New York, NY
01.2024 - 05.2024
- Commercialization plan for rapid testing kits of tuberculosis and non-tuberculosis mycobacterium at Lower-to-Middle-Income countries in Africa and Asia.
- Generating business analysis for reporter based mycobacteriophage drug susceptibility testing diagnostics for global mycobacterium infections.
- Analyzing and constructing financial plan and market projection for the next three years as a lean biotech startup.
- Conducting market analysis for Drug Susceptibility Testing (DST) for tuberculosis & potentially non-tuberculosis mycobacterium infections across the world.
- Developing a market campaign strategy for the DST market.
Graduate Research Assistant
Yeshiva University
New York, NY
08.2023 - 02.2024
- Research: Male Infertility: The Effect of SUMO Protein Inhibition on Sertoli Cells & Regulation of spermatogenesis by SUMO proteins.
- Focus on understanding of the role of SUMOylation in testicular cells.
- Experiments using cell lines and mouse model with inhibited SUMOylation to understand how spermatogenesis is affected.
- Looked into specific targets regulated by SUMOylation during spermatogenesis to better understand molecular regulation of spermatogenesis.
Project Manager - Intern
Parikh Network LLC
Rutherford, NJ
05.2023 - 08.2023
- Presented concepts to clients, obtained feedback, negotiated timelines & budgets to ensure that all deadlines are maintained in a team setting.
- Developed & maintained solid client relationship, ensured all regulatory, legal compliance and branding guidelines are followed.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Coordinated cross-functional teams and resolved conflicts, ensuring that efforts contributed to overall business growth.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, risk mitigation plans in mind and alignment with organizational goals.
Education
Master of Science - Biotechnology Management & Entrepreneurship, Biological & Biomedical Sciences, Entrepreneurship & Management Sciences
Yeshiva University
New York, NY05.2024
Bachelor of Science - Pharmaceutical Sciences
Gujarat Technological University
Gujarat, India01.2021
Skills
- Biotech & Pharmaceutical expertise
- Gene Expression Analysis
- Molecular Biology Expertise
- Project management abilities
- Entrepreneurial & technical mindset
- Regulatory Knowledge & intellectual properties awareness
- Communication & networking
- Adaptability
- Critical & strategic thinking
- Problem-solving & team Building
- Risk assessment
- Project management
- Document management
- Quality control
- GMP audits
Accomplishments
- Collaborated with team of 15 in the development of budget and risk mitigation plans as project manager-intern.
- By research found the best SiRNA for SUMOYLATION in mice testicular cells.
- Thesis on Bioanalytical techniques validation & development, Levofloxacin intravenous infusion using different instruments like HPLC & GAS Chromatography under controlled and supervised environment.
- Developed complex financial models to forecast budgets, inform strategic investment decisions, and improve forecast accuracy by 15%.
- Conducted in-depth financial analysis to identify trends and opportunities, contributing to a 10% reduction in costs. Prepared detailed financial reports and presentations for senior management, enhancing the decision-making process.
References
References available upon request.
Timeline
Quality Assurance Person
Kesar Pharma PVT. LTD.
05.2024 - Current
Project: Commercialization Plan
Ranaqua Biosciences, LLC
01.2024 - 05.2024
Graduate Research Assistant
Yeshiva University
08.2023 - 02.2024
Project Manager - Intern
Parikh Network LLC
05.2023 - 08.2023
Master of Science - Biotechnology Management & Entrepreneurship, Biological & Biomedical Sciences, Entrepreneurship & Management Sciences
Yeshiva University
Bachelor of Science - Pharmaceutical Sciences
Gujarat Technological University
Similar Profiles
Nishant PandeyNishant Pandey
Sales Coordinator & Data Entry Operator at KESAR EARTH SOLUTIONS (Liugong INDIA PVT LTD-CG DEALER)Sales Coordinator & Data Entry Operator at KESAR EARTH SOLUTIONS (Liugong INDIA PVT LTD-CG DEALER)
SEASONRAJ Y R SEASONRAJ Y R null
Area Sales Manager at EAST WEST PHARMA PHARMA INDIA PVT LTDArea Sales Manager at EAST WEST PHARMA PHARMA INDIA PVT LTD
Jaikib ChambyalJaikib Chambyal
Cook at Kesar Sweets and RestaurantCook at Kesar Sweets and Restaurant
Elsy TorresElsy Torres
Surgical Assistant at Texas Oral Surgery Group (a division of OMS360)Surgical Assistant at Texas Oral Surgery Group (a division of OMS360)
Ahmed HusseinAhmed Hussein
Founding Go-to-Market Associate (First Sales Hire) at Conduit CommerceFounding Go-to-Market Associate (First Sales Hire) at Conduit Commerce